Feasibility of TAP for XLIF Surgery

NCT05497908 | Completed

• 1 other identifier: f/2022/050
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Key questions of this feasibility trial will be the feasibility of performing the TAP block in XLIF patients, screen for safety of the block and preliminary investigate the influence on pain control and quality of recovery. The investigators hypothesize that visualization of lateral TAP will be superior to visualization of posterior TAP, protocol adherence and safety profile to be excellent and both blocks to be superior in terms of analgesia compared to no block.

Conditions

Pain, Postoperative

Keywords

eXtreme Lateral Interbody Fusion (XLIF) surgery; transversus abdominis plane (TAP) block

Outcome Measures

Primary Outcomes (1)

• Identification rate of the correct transverse abdominis plane block

  Identification rate of the correct transverse abdominis plane block by ultrasound as assessed by a five-point-scale which can be found as supplement (very good -good - acceptable -poor - very poor)

  immediately after the surgery

Secondary Outcomes (10)

• Total morphine consumption

  12 hours after surgery

• Patient recruitment rate

  through study completion, an average of 1 year

• Adherence rate to protocol

  12 hours after surgery

• total operation room time

  during the surgery

• Assessment of the number of patients with local anesthestia systemic toxicity (LAST)

  during the stay at the PACU

Study Arms (3)

Transversus abdominis plane (TAP) block via lateral approach

EXPERIMENTAL

This group receives a Transversus abdominis plane (TAP) block via lateral approach

Procedure: TAP block via lateral approach

Transversus abdominis plane (TAP) block via posterior approach

EXPERIMENTAL

This group receives a Transversus abdominis plane (TAP) block via posterior approach

Procedure: TAP block via posterior approach

Control group

NO INTERVENTION

The control group receives no TAP block.

Interventions

TAP block via lateral approach PROCEDURE

TAP block via lateral approach

Transversus abdominis plane (TAP) block via lateral approach

TAP block via posterior approach PROCEDURE

TAP block via posterior approach

Transversus abdominis plane (TAP) block via posterior approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Scheduled for elective lumbar XLIF surgery
• level
• multilevel
• Patient being able to give informed consent
• Patient being able to understand and use the PCIA system
• Body Mass Index (BMI) ≤ 35 kg/m2

You may not qualify if:

• \- Refusal to participate
• Chronic strong opioid use (WHO analgesic ladder step 3)
• Allergy to local anesthetics
• Antecedents of lumbar back surgery
• Pregnancy

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stafmember Anesthesiology and Intensive Care, Head of Science department Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 11, 2022
• Study Start: September 2, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)